Metabolic Imaging of Neurological Disease | NCT06900244

Studies
Metabolic Imaging of Neurological Disease

NCT06900244

Sponsor

University of Oxford

Status

Enrolling by invitation

Last Update Posted

Mar 28, 2025Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Multiple Sclerosis

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2021Actual

Primary Completion Date

Jun 2027Estimated

Completion Date

Jun 2027Estimated

First Submitted Date

Mar 17, 2025

First Submission Date that Met QC Criteria

Mar 26, 2025

First Posted Date

Mar 28, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2025

Last Update Posted Date

Mar 28, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Multiple Sclerosis is a chronic condition that shows changes in the way that the brain consumes sugar. It is also known that there are a number of metabolic and inflammatory sequelae following a transient ischemic attack/stroke (hereby referred to collectively as 'stroke'). This study will use a powerful new technology ('hyperpolarised magnetic resonance imaging') to detect these changes in the brains of people with multiple sclerosis and Clinically Isolated Syndrome (CIS) or following a stroke when compared to a group of healthy volunteers. It will be undertaken at the University of Oxford, and each participant will undergo up to 4 scans over the course of three years.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

250Estimated

Label	Type	Description	Intervention Names
Multiple Sclerosis		All phenotypes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To detect 13C metabolism in healthy participants and MS, CIS, and Stroke patients.	Baseline: Imaging of 13C labelled downstream metabolites from the injected metabolically active substrates in healthy participants and MS/CIS/Stroke patients, and compare to healthy volunteers	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of MS or stroke

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

99 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Healthy volunteers and people with MS / stroke

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Oxford		Oxford			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Upon reasonable request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided